On-body injector and method of use

ABSTRACT

An on-body injector and method of use including an on-body injector for use with an injection device. The on-body injector includes a bolus reservoir; a bolus injection needle in fluid communication with the bolus reservoir, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap between the bolus injection needle tip and the injection port; and a button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis. The button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port. The button is further operable to advance a plunger through the bolus reservoir to deliver a predetermined bolus volume to the patient through the injection flow path.

CROSS REFERENCES TO RELATED APPLICATIONS

This application is a continuation of and claims the benefit of U.S.patent application Ser. No. 14/134,749, filed on Dec. 19, 2013, entitledON-BODY INJECTOR AND METHOD OF USE, which is a continuation-in-part ofand claims the benefit of U.S. patent application Ser. No. 14/052,929,filed on Oct. 14, 2013, entitled THERAPEUTIC AGENT INJECTION DEVICE,which are incorporated by reference in their entireties herein.

TECHNICAL FIELD

The technical field of this disclosure is personal medical systems,particularly, on-body injectors and methods of use.

BACKGROUND OF THE INVENTION

Certain medical conditions or diseases require that patientsintermittently inject a drug or therapeutic agent subcutaneously tomaintain the medical condition or disease under control. Multiple dailyinjections (MDIs) may be required. One such medical condition isdiabetes, for which insulin is injected to regulate blood glucose. Anestimated twenty-six million people in the United States, or about 8% ofthe population, have diabetes. This percentage is expected to increasein the near-term as the population ages.

Certain patients are unlikely or unable to follow the drug regimenrequired to maintain their medical condition under control. Somepatients are squeamish about injecting the drug themselves and otherssuffer adverse effects from repeated injections, such as bruising at theinjection site. To accommodate such patients, injection ports have beendeveloped which only require that the patient puncture their skin everyfew days to install an injection port, rather than injecting with aneedle into their skin numerous times a day. Injection ports employ acannula inserted subcutaneously, and the patient injects the drug intothe injection port adhering to their skin rather than directly intotheir cutaneous tissue.

Unfortunately, injection ports still require that the patient administerthe therapeutic agent repeatedly throughout the day. Injection portswith dedicated reservoirs allowing bolus injection have been developed,but maintain a continuous flow path and run the risk of inadvertentbolus injection. Although these problems can be remedied with adedicated electronic insulin pump, many patients are unwilling or unableto use a dedicated insulin pump due to the expense and complication.Such systems present other obstacles to the patient, such as theinability to choose different therapy options based on specific dailyneeds or activity.

It would be desirable to have an on-body injectors and methods of usethat would overcome the above disadvantages.

SUMMARY OF THE INVENTION

One aspect of the invention provides an on-body injector for use with apatient with an injection device having an injection port in fluidcommunication with a delivery tube and the injection port lying on aninjection axis. The on-body injector includes a bolus reservoir; a bolusinjection needle in fluid communication with the bolus reservoir, thebolus injection needle having a bolus injection needle tip aligned withthe injection port, the bolus injection needle being slideably biasedaway from the injection port to define a gap between the bolus injectionneedle tip and the injection port; and a button operably connected tothe bolus injection needle to slide the bolus injection needle along theinjection axis. The button is operable to advance the bolus injectionneedle tip to close the gap and advance the bolus injection needle tipinto the injection port to form an injection flow path from the bolusreservoir, through the bolus injection needle, through the deliverytube, and into the patient. The button is further operable to advance aplunger through the bolus reservoir to deliver a predetermined bolusvolume to the patient through the injection flow path.

Another aspect of the invention provides an on-body injector for usewith a patient with an injection device having an introducer port influid communication with a delivery tube. The on-body injector includesa pressurized reservoir; a flow restrictor disposed between thepressurized reservoir and the delivery tube, the flow restrictor beingtubing having a length and interior diameter selected to provide adesired pressure drop; and a fill port in fluid communication with thepressurized reservoir.

Another aspect of the invention provides a method of use for an on-bodyinjector with an injection device for delivering a predetermined bolusvolume to a patient, the method including deploying the injection devicein the patient, the injection device having a delivery tube placed inthe patient and an injection port in fluid communication with thedelivery tube; securing the on-body injector to the injection device,the on-body injector having a bolus injection needle aligned with andspaced apart from the injection port; depressing a button on the on-bodyinjector to advance the bolus injection needle into the injection port;and further depressing the button to deliver the predetermined bolusvolume from the on-body injector through the bolus injection needle,through the delivery tube, and into the patient.

The foregoing and other features and advantages of the invention willbecome further apparent from the following detailed description of thepresently preferred embodiments, read in conjunction with theaccompanying drawings. The detailed description and drawings are merelyillustrative of the invention, rather than limiting the scope of theinvention being defined by the appended claims and equivalents thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-4 are perspective, section, perspective, and explodedperspective views, respectively, of one embodiment of an injectiondevice made in accordance with the invention.

FIGS. 5A-5C are perspective views of one embodiment of an injectiondevice made in accordance with the invention.

FIG. 6 is a section perspective view of one embodiment of an injectiondevice made in accordance with the invention.

FIGS. 7-11 are perspective, perspective, section, section, andperspective section views, respectively, of one embodiment of aninjection device made in accordance with the invention.

FIGS. 12A-12D are side and section views of needleless pen injectors foruse with an injection device made in accordance with the invention.

FIGS. 13A-13F are section views of pop-up indicator ports for use withan injection device made in accordance with the invention.

FIGS. 14A & 14B are perspective views of one embodiment of an injectiondevice made in accordance with the invention.

FIGS. 15-20 are front perspective, top side, left side, bottom side,bottom perspective, and detail views, respectively, of one embodiment ofa body for an injection device made in accordance with the invention.

FIG. 21 is a perspective view of one embodiment of an introducer septumfor use in an injection device made in accordance with the invention.

FIG. 22 is a section view of an injection device made in accordance withthe invention including the introducer septum of FIG. 21.

FIG. 23 is a perspective view of one embodiment of a septum for use inan injection device made in accordance with the invention.

FIGS. 24A & 24B are top side and section views, respectively, of oneembodiment of a septum for use in an injection device made in accordancewith the invention.

FIG. 25 is a perspective view of one embodiment of an on-body injectorfor use with an injection device made in accordance with the invention.

FIG. 26 is a partial perspective view of portions of one embodiment ofan on-body injector for use with an injection device made in accordancewith the invention.

FIG. 27 is a partial perspective view of portions of one embodiment ofan on-body injector for use with an injection device made in accordancewith the invention.

FIG. 28 is a section view of one embodiment of an injection device andon-body injector for use with an injection device made in accordancewith the invention.

FIG. 29 is a block diagram of one embodiment of an injection device andon-body injector made in accordance with the invention.

FIG. 30 is a flow chart of a method of use for an on-body injector inaccordance with the invention.

FIG. 31 is a block diagram of one embodiment of an injection device andelectronic on-body injector made in accordance with the invention.

FIGS. 32A-32C are wave form diagrams of bolus, basal, and basal pumpdrive signals for an electronic injector made in accordance with theinvention.

FIGS. 33A-33C are schematic diagrams of a piezoelectric MEMS pump foruse in an electronic injector made in accordance with the invention.

FIGS. 34A-34C are an exploded perspective view, a partial perspectiveview, and a partial perspective view of an injection device andelectronic on-body injector made in accordance with the invention.

FIG. 35 is a block diagram of one embodiment of an electronic injectormade in accordance with the invention.

FIGS. 36A-36D are a perspective view, a top view, a side view, and apartial perspective view of an electronic injector made in accordancewith the invention.

FIGS. 37A-37E are a perspective view, a top view, a side view, anexploded perspective view, and a partial top view of an electronicinjector made in accordance with the invention.

FIG. 38 is a schematic cross section view of an electronic injector madein accordance with the invention.

DETAILED DESCRIPTION

FIGS. 1-5C, in which like elements share like reference numbers, arevarious views of one embodiment of an injection device made inaccordance with the invention. The injection device includes anintroducer port along an introducer axis and an injection port along aninjection axis, with the injection axis being non-collinear with theintroducer axis. In this embodiment, the injection axis is at an angleto and intersects with the introducer axis.

FIG. 1 is a perspective view of the injection device 100 including abody 110 and a patch 120 attached to the body 110. The patch 120 isoperable to adhesively attach the injection device 100 to a patient (notshown). The body 110 has a port face 112, with an introducer port 130and an injection port 140 on the port face 112. The introducer port 130is used to place a delivery tube subcutaneously in the patient. Theinjection port 140 is used by the patient to inject a therapeutic agent,which as defined herein can be any liquid such as a liquid including atherapeutic agent, drug, diagnostic agent, or the like. The body 110also includes cutouts 160. Those skilled in the art will appreciate thatthe introducer port 130 can be too small to be effectively used by apatient for injection, but could be used to inject a therapeutic agent,such as a bolus injection using a mechanically attached device, asdesired for a particular application.

FIG. 2 is a section view of the injection device 100, the sectionbisecting the introducer port 130 and the injection port 140, andincludes the introducer axis 134 and injection axis 144. An axis asdefined herein generally follows the centerline of an associated channelthrough an associated port. The body 110 has a port face 112 and apatient face 114. A delivery tube 150 for subcutaneous delivery of thetherapeutic agent projects from and is generally perpendicular to thepatient face 114. The delivery tube 150 is operably connected to theintroducer port 130 and defines an introducer axis 134 along theintroducer channel 132, the delivery tube 150 being in fluidcommunication with the injection port 140. The introducer port 130includes an introducer channel 132, with an introducer port cover 135and an introducer septum 136 disposed in the introducer channel 132. Theinjection port 140 includes an injection channel 142 defining aninjection axis 144 with an injection septum 146 disposed in theinjection channel 142. In one embodiment, the introducer septum 136and/or the injection septum 146 is self sealing, such that each of theseptums block fluid flow through the septum after a needle has been putthrough the septum then removed, preventing fluid flow from the port. Inthis embodiment, the injection axis 144 is at an angle to and intersectswith the introducer axis 134. In one example, the delivery tube 150 is aflexible cannula and a needle hub assembly can be used to place thedelivery tube 150 subcutaneously in the patient. In another example, thedelivery tube 150 is a rigid needle and the delivery tube 150 can beplaced subcutaneously in the patient with or without a needle hubassembly.

FIG. 3 is a perspective view of the injection device 100 with a needlehub assembly 170. The needle hub assembly 170 includes a needle hub 172and a needle 174 attached to the needle hub 172. The needle 174 of theneedle hub assembly 170 is inserted through the introducer port 130 andthrough the delivery tube 150 along the introducer axis 134. The needlehub assembly 170 can be used to add rigidity to the delivery tube 150during implantation when the delivery tube 150 is a flexible cannula.

FIG. 4 is an exploded perspective view of the injection device with aneedle hub assembly. A needle guard 176 disposed around the needle 174can be used to protect the needle 174 and the delivery tube 150 when theinjection device and needle hub assembly are assembled for shipping. Thevarious parts of the injection device and needle hub assembly can beconnected by interference fit, adhesive, welding, and/or any othermethod of attachment suitable for a particular application.

FIGS. 5A-5C are perspective views of various applications of theinjection device made in accordance with the invention. Referring toFIG. 5A, a syringe 190 can be used to deliver a therapeutic agentthrough the injection port 140 of the injection device 100. The syringecan be a conventional syringe, a standard insulin pen, or a needlelesssyringe. The needle length of a conventional syringe or standard insulinpen can be of any length because the injection axis is non-collinearwith the introducer axis, such that a longer needle does not damage theinjection device. In one embodiment, the injection port 140 is adaptedto be mateable with the syringe 190, with a socket, fitting, or thelike, to increase ease of use. In one example, the injection port 140 isa socket with a socket needle which pierces a foil front end of aneedleless syringe when the needleless syringe is seated in the socket.The needleless syringe itself has no needle in this example.

Referring to FIG. 5B, an on-body injector 192 is mateable with theinjection port 140 of the injection device 100 and can be used todeliver a therapeutic agent through the injection port 140. The on-bodyinjector 192 can include a reservoir to hold the therapeutic agent. Inone embodiment, the on-body injector 192 can deliver a basal and/orbolus dose of the therapeutic agent.

Referring to FIG. 5C, an extendable tube 194 can be used to deliver atherapeutic agent through the injection port 140. The extendable tube194 includes a port connector 195, a tube 196, and an external devicefitting 197, all being in fluid communication. The port connector 195 isin fluid communication with the injection port 140 with a needle ormateable fitting to deliver the therapeutic agent through the injectionport 140. The external device fitting 197 is connectable to an externaldevice, such as a wearable insulin pump or an infusion tubing line to agravity fed container.

FIG. 6 is a section perspective view of one embodiment of an injectiondevice made in accordance with the invention. In this embodiment, anupper body portion is rotatable about the introducer axis independent ofa lower body portion, so that the injection axis can be positioned at adesired rotary angle regardless of the initial placement of the patch onthe patient. This allows the patient to select a rotary position for theinjection port that is convenient for injection of the therapeuticagent.

The body of the injection device can have a first body portion includingthe port face and a second body portion including the patient face, thefirst body portion and the second body portion being rotatably connectedwith a flange, the first body portion and the second body portion beingindependently rotatable about the introducer axis.

The body 210 of the injection device 200 includes an upper body portion202 and a lower body portion 204. The upper body portion 202 and lowerbody portion 204 are rotatably connected with a flange 206 so that theupper body portion 202 and the lower body portion 204 can rotateindependently about the introducer axis 234 defined by the delivery tube250 along the introducer channel 232. The upper body portion 202 has aport face 212 and the lower body portion 204 has a patient face 214. Apatch 220 is attached to the patient face 214 and is operable toadhesively attach the injection device 100 to a patient (not shown).

The delivery tube 250 for subcutaneous delivery of a therapeutic agentprojects from and is generally perpendicular to the patient face 214.The delivery tube 250 is operably connected to the introducer port 230,the delivery tube 250 being in fluid communication with the injectionport 240. The introducer port 230 includes an introducer channel 232,with an introducer septum 236 disposed in the introducer channel 232.The injection port 240 includes an injection channel 242 defining aninjection axis 244 with an injection septum 246 disposed in theinjection channel 242.

The injection axis 244 is non-collinear with the introducer axis 234. Inthis embodiment, the injection axis 244 is at an angle to and intersectswith the introducer axis 234. In one example, the delivery tube 250 is aflexible cannula and a needle hub assembly can be used to place thedelivery tube 250 subcutaneously in the patient. In another example, thedelivery tube 250 is a rigid needle and the delivery tube 250 can beplaced subcutaneously in the patient with or without a needle hubassembly.

In operation, the patch 220 is attached to the patient and the deliverytube 250 inserted in the patient for subcutaneous delivery of atherapeutic agent. The injection port 240 in the upper body portion 202can be rotated about the introducer axis 234 even though the lower bodyportion 204 is at a fixed position on the patient since the lower bodyportion 204 is attached to the patient by the patch 220.

FIGS. 7-11, in which like elements share like reference numbers, arevarious views of one embodiment of an injection device made inaccordance with the invention. The injection device includes anintroducer port along an introducer axis and an injection port along aninjection axis, with the injection axis being non-collinear with theintroducer axis. In this embodiment, the injection axis is parallel toand does not intersect with the introducer axis.

The injection device for delivering a therapeutic agent to a patient caninclude a body, the body having a patient face and a port face oppositethe patient face, the port face having an introducer port including anintroducer channel and an injection port including an injection channel,the introducer channel being in fluid communication with the injectionchannel through a cross channel, the injection channel defining aninjection axis; a delivery tube for subcutaneous delivery of thetherapeutic agent to the patient, the delivery tube projecting from andbeing generally perpendicular to the patient face, the delivery tubedefining an introducer axis and being in fluid communication with theinjection port; and a patch, the patch being attached to the patientface and being operable to adhesively attach to the patient; wherein theinjection axis is parallel to the introducer axis.

FIG. 7 is a perspective view of the injection device 300 including abody 310 and a patch 320 attached to the body 310. The patch 320 isoperable to adhesively attach the injection device 300 to a patient (notshown). The body 310 has a port face 312, with an introducer port 330 onthe port face 312. The introducer port 330 is used to place a deliverytube subcutaneously in the patient. In this example, an optionalinjection cap 302 secured to the body 310 to protect an injection port,which is used by the patient to inject a therapeutic agent.

FIG. 8 is a perspective view of the injection device 300 with theoptional injection cap removed to expose the injection port 340. In thisexample, the body 312 includes threads 306 to secure the optionalinjection cap to the body and an optional O-ring 304 to seal the areaaround the injection port 340 when the optional injection cap is securedto the body.

FIG. 9 is a section view of the injection device 300, the sectionbisecting the introducer port 330 and the injection port 340 andincluding the introducer axis 334 and injection axis 344. The body 310has a port face 312 and a patient face 314. A delivery tube 350 forsubcutaneous delivery of the therapeutic agent projects from and isgenerally perpendicular to the patient face 314. The delivery tube 350is operably connected to the introducer port 330 and defines anintroducer axis 334 along the introducer channel 332, the delivery tube350 being in fluid communication with the injection port 340. Theintroducer port 330 includes an introducer channel 332, with anintroducer septum 336 disposed in the introducer channel 332. Theinjection port 340 includes an injection channel 342 defining aninjection axis 344 with an injection septum 346 disposed over theinjection channel 342. In this embodiment, the injection axis 344 isparallel to and does not intersect with the introducer axis 334. A crosschannel 343 connects the injection channel 342 to the introducer channel332. In one example, the delivery tube 350 is a flexible cannula and aneedle hub assembly can be used to place the delivery tube 350subcutaneously in the patient. In another example, the delivery tube 350is a rigid needle and the delivery tube 350 can be placed subcutaneouslyin the patient with or without a needle hub assembly.

FIG. 10 is a section view of the injection device 300 with a needle hubassembly 370 and a needle guard 376. The needle hub assembly 370includes a needle hub 372 and a needle 374 attached to the needle hub372. The needle 374 of the needle hub assembly 370 is inserted throughthe introducer port 330 and through the delivery tube 350 along theintroducer axis 334. The needle hub assembly 370 can be used to addrigidity to the delivery tube 350 when the delivery tube 350 is aflexible cannula. The needle hub assembly 370 can optionally be usedwhen the delivery tube 350 is a rigid needle. A needle guard 376disposed around the needle 374 can be used to protect the needle 374 andthe delivery tube 350 when the injection device and needle hub assemblyare assembled for shipping.

FIG. 11 is a perspective section view of the injection device with aninjection adapter assembly. For clarity of illustration, the crosssection cut of the injection device 300 in the illustration bisects theintroducer port 330 and the injection port 340, and includes theintroducer axis 334 and injection axis 344. The cross section cut of theinjection adapter assembly 400 in the illustration includes theinjection axis 344 and is perpendicular to the section of the injectiondevice 300. The injection adapter assembly 400 screws onto the injectiondevice 300 using the threads 306 on the body 310 to secure theneedleless pen injector to the body 310, with the O-ring 304 sealingaround the interface between the adapter septum 420 and the injectorseptum 346. Those skilled in the art will appreciate that the mateableconnection securing the needleless pen injector to the body is notlimited to threads and can be any mateable connection desired for aparticular application.

In this embodiment, the injection adapter assembly 400 is adapted toreceive a needleless pen injector (not shown). The adapter body 410defines a recess 412 adapted to receive a tip of the needleless peninjector. In this example, the needleless pen injector includes threadson its outer diameter complementary to the adapter threads 414 on theinner diameter of the adapter body 410. The tip of the needleless peninjector is screwed into the recess 412 so that the adapter needle 416is received in the needleless pen injector, accessing the therapeuticagent contained within the needleless pen injector by piercing a foil onthe tip of the needleless pen injector or accessing a pen injector portadapted to receive the adapter needle 416. With the needleless peninjector secured in the injection adapter assembly 400, pressure appliedto the therapeutic agent enclosed in the needleless pen injector forcesthe therapeutic agent through the adapter needle 416 and the adapterseptum 420 into the injection device 300, where the therapeutic agentpasses through the injector septum 346 into the injection port 340,through the injection channel 342, the cross channel 343, and thedelivery tube 350, and into the patient.

Those skilled in the art will appreciate that a variety of interfacescan be used between the needleless pen injector, the injection adapterassembly 400, and the injection device 300. In the embodiment of FIG.11, the adapter septum 420 and the injector septum 346 are permeable sothat the therapeutic agent passes through the adapter septum 420 and theinjector septum 346. The septums can be hydrophilic when used with theneedleless pen injector to allow the therapeutic agent to pass through.In another embodiment, the injector septum can include a slit valveoperable to open on receiving a stub tube at the tip of the needlelesspen injector. In yet another embodiment, the injector septum can includea slit valve which is open by a mechanical lever that pushes open andspread the slit valve when the needleless pen injector is received inthe injection adapter assembly. In yet another embodiment, theneedleless pen injector is interlocked with the injection adapterassembly so that no therapeutic agent can be dispensed from theneedleless pen injector until the needleless pen injector is fullyengaged with the injection adapter assembly.

FIGS. 12A-12D are various views of needleless pen injectors for use withan injection device made in accordance with the invention. Each of theneedleless pen injectors is provided with a manual or automaticpressurization to force the therapeutic agent held within the needlelesspen injector into the injection device and patient, once the needlelesspen injector has been fully engaged with an injection adapter assembly.

FIG. 12A is a side view of the tip of a needleless pen injector 500having a barrel 502 to contain a therapeutic agent and optional threads504 for use with an adapter body having threads on the inner diameter.The end 506 of the needleless pen injector 500 can be adapted toaccommodate the particular design of an injection adapter assembly for aparticular application. FIG. 12B is a section view of the tip of aneedleless pen injector 510 having a barrel 512 to contain a therapeuticagent and a foil 516 across the end of the needleless pen injector 510.The foil 516 can be pierced by an adapter needle in the injectionadapter assembly (shown in FIG. 11) to provide fluid communicationbetween the needleless pen injector 510 and the injection device throughthe injection adapter assembly. FIG. 12C is a section view of the tip ofa needleless pen injector 520 having a barrel 522 to contain atherapeutic agent and a pen port 526 at the end of the needleless peninjector 520. The pen port 526 can receive an adapter needle in theinjection adapter assembly (shown in FIG. 11) to open the pen port 526and provide fluid communication between the needleless pen injector 520and the injection device through the injection adapter assembly. FIG.12D is a section view of the tip of a needleless pen injector 530 havinga barrel 532 to contain a therapeutic agent and a stub tube 536 at theend of the needleless pen injector 530. The stub tube 536 is operable toopen a slit valve on the injector septum of the injection device.

FIGS. 13A-13F, in which like elements share like reference numbers, aresection views of pop-up indicator ports for use with an injection devicemade in accordance with the invention. Because the introducer port andthe injection port of the injection device are both in fluidcommunication with the delivery tube, flow blockage in the delivery tubecan cause an increase in pressure at both ports when the patientattempts to inject a therapeutic agent. The flow blockage/pressureincrease can be detected by the patient, indicating that the therapeuticagent is not being delivered, with a pop-up indicator port in the portnot being used for injection. During injection, the membrane of thepop-up indicator port is close to the body of the injection device undernormal conditions, and extends from the body of the injection devicewhen the delivery tube is blocked and the pressure increases above apredetermined pressure.

The pop-up indicator can be disposed in the introducer channel, thepop-up indicator having a normal state when pressure in the introducerchannel is normal and an alarm state when pressure in the introducerchannel exceeds a predetermined value.

FIGS. 13A & 13B are section views of a pop-up indicator port 600 with afolded membrane 602 installed as the introducer port. The pop-upindicator port 600 is installed in the introducer channel 632 of thebody 610 along the introducer axis 634, and is in fluid communicationwith the injection channel. A self-closing port 604 in the membrane 602allows a needle of a needle hub assembly to pass through the membrane602 when a needle hub assembly is used to implant the injection device.No self-closing port is required if a needle hub assembly is not used toimplant the injection device. Referring to FIG. 13A, the pop-upindicator port 600 is in the normal state with normal pressure in theintroducer channel 632, with the membrane 602 folded on itself.Referring to FIG. 13B, the pop-up indicator port 600 is in the alarmstate due to pressure in the introducer channel 632 exceeding apredetermined value. The pressure occurs when a therapeutic agent isbeing injected into the injection port, which is in fluid communicationwith the introducer channel 632, while the delivery tube is blocked. Inthe alarm state, the membrane 602 unfolds to extend from the body 610.

FIGS. 13C & 13D are section views of a pop-up indicator port 600 with anaccordion membrane 612 installed as the introducer port. Referring toFIG. 13C, the pop-up indicator port 600 is in the normal state withnormal pressure in the introducer channel 632, with the membrane 612pleated like an accordion. Referring to FIG. 13D, the pop-up indicatorport 600 is in the alarm state due to pressure in the introducer channel632 exceeding a predetermined value. The pressure occurs when atherapeutic agent is being injected into the injection port, which is influid communication with the introducer channel 632, while the deliverytube is blocked. In the alarm state, the membrane 612 uncompresses thepleats to extend from the body 610.

FIGS. 13E & 13F are section views of a pop-up indicator port 600 with adeformable membrane 622 installed as the introducer port. Referring toFIG. 13E, the pop-up indicator port 600 is in the normal state withnormal pressure in the introducer channel 632, with the membrane 622extending across the introducer channel 632. Referring to FIG. 13F, thepop-up indicator port 600 is in the alarm state due to pressure in theintroducer channel 632 exceeding a predetermined value. The pressureoccurs when a therapeutic agent is being injected into the injectionport, which is in fluid communication with the introducer channel 632,while the delivery tube is blocked. In the alarm state, the material ofthe membrane 622 deforms under pressure to extend from the body 610. Inanother embodiment, the material of the membrane 622 can deformssufficiently to allow the therapeutic agent to leak through the membrane622, providing additional indication of the high pressure and deliverytube blockage.

Those skilled in the art will appreciate that the material anddimensions of the parts of the membrane (folds and/or pleats) can beselected as desired for a particular application. In one embodiment, thematerial is resilient, so that the membrane returns to the normal stateafter being in the alarm state. In another embodiment, the material isdeformable so that the membrane remains extending from the body afterthe pressure is relieved and the alarm state clears. The extendedmembrane reminds the patient of the delivery tube blockage and the needto replace the injection device. Exemplary materials for the membraneinclude silicone rubber or the like.

FIGS. 14A & 14B, in which like elements share like reference numbers,are perspective views of one embodiment of an injection device made inaccordance with the invention. In this embodiment, the injection deviceincludes a tube with an external device fitting, so that the injectiondevice can be placed in a remote location and attached to an injectionpump.

FIG. 14A is a perspective view of the injection device 700 in a storedconfiguration, the injection device 700 including a body 710 and a patch720 attached to the body 710. The patch 720 is operable to adhesivelyattach the injection device 700 to a patient (not shown). The body 710has a groove 702 around its outer circumference operable to receive tube794 in the stored configuration. One end of the tube 794 is in fluidcommunication with an injection port (not shown) of the injection device700 to deliver a therapeutic agent into the body of a patient. The otherend of the tube 794 is in fluid communication with the external devicefitting 797, which can be extended to a convenient location when theinjection device 700 is in a difficult to access location or which canbe connected to an injection pump (not shown). In this example, the body710 includes a fitting receiver 704 operable to receive and store theexternal device fitting 797 when the injection device 700 is in thestored configuration with the tube 794 wrapped around the body 710. FIG.14B is a perspective view of the injection device 700 in a deployedconfiguration, with the external device fitting 797 uncoupled from thefitting receiver 704 and the tube 794 uncoiled from the groove 702 inthe body 710. In operation, the injection device 700 can be placed on aremote location on the body of the patient, such as a remote locationnot normally accessible for injection by conventional means, and thetube 794 extended to allow convenient connection to an injection pump.

FIGS. 15-20, in which like elements share like reference numbers, arevarious views of one embodiment of a body for an injection device madein accordance with the invention. The body includes cutouts to provideinspection and ventilation at the attachment point of the injectiondevice to the patient.

The single piece body for an injection device can include a planar deckhaving a patient face, the planar deck having cutouts around and throughthe planar deck, the planar deck including a delivery tube port on thepatient face; a port segment attached opposite the patient face of theplanar deck, the port segment including an introducer port including anintroducer channel and an injection port including an injection channelthe introducer channel being in fluid communication with the injectionchannel and the delivery tube port; and attachment projectionsprotruding from the patient face. In one embodiment, the attachmentprojections are operable for plastic welding.

The single piece body can be used with an injection device fordelivering a therapeutic agent to a patient including the single piecebody. The injection device further includes a delivery tube forsubcutaneous delivery of the therapeutic agent to the patient, thedelivery tube projecting from and being generally perpendicular to thepatient face, the delivery tube being in fluid communication with theinjection port; and a patch, the patch being plastically welded to theattachment projections and being operable to adhesively attach to thepatient.

FIGS. 15 & 16 are a front perspective view and a top side view,respectively, of a body 810 including a port face 812. The port face 812includes an introducer port 830 and an injection port 840. The body 810has a generally planar deck 804 with cutouts 860 spaced around andpassing through the planar deck 804. The body 810 also has a portsegment 806 rising above the planar deck 804 and including theintroducer port 830 and an injection port 840. The body 810 is a singlepiece body, which is defined herein as a body formed as a single pieceand is not a group of separate pieces assembled to form the body.

FIG. 17 is a left side view of the body 810. The patient face 814 isopposite the port face 812 on the planar deck 804 and is operable toconnect the body 810 to a patch (not shown) to adhesively attach theinjection device to a patient. In this embodiment, the patient face 814of the planar deck 804 includes a number of attachment projections 820(in this example, the attachment projections 820 being bumps) protrudingfrom the planar deck 804 to allow a patch to be plastically welded tothe body 810. Those skilled in the art will appreciate that differentattachment projections, such as truncated pyramids, bumps, radial lines,concentric rings, or the like, can be selected as desired for aparticular application. In yet another embodiment, the patch can beattached to the body 810 with an adhesive.

FIGS. 18 & 19 are a bottom side view and a bottom perspective view,respectively, of the body 810. The attachment projections 820 arearranged around the outer circumference 823 of the patient face 814,around an inner circle 822 about a delivery tube port 825 on theintroducer axis 834, and along diameter segments 824 between the outercircumference 823 and the inner circle 822 which follow the length ofthe port segment. In this example, the attachment projections 820 aretruncated pyramids.

FIG. 20 is a section view of the planar deck 804 of the body 810 alongthe outer circumference through the attachment projections 820. In thisexample, the body 810 is plastically welded to a patch 830, which isattached to the skin 832 of a patient. The attachment projections 820are deformed from the truncated pyramid to a flattened, rounded shapefrom welding the attachment projections 820 to the patch 830 at eachfixation point 836. In this example, the tips of the attachmentprojections 820 are welded into the patch 830, i.e., the tips of theattachment projections rest below the surface of the patch at thefixation points 836 where the attachment projections 820 join the patch830. In cross section through adjacent attachment projections 820, thepatient face 814 and the patch 830 define a ventilation gap 838 toprovide ventilation and air circulation between the planar deck 804 andthe patch 830, cooling the skin 832 across the patch 830 from theventilation gap 838.

Those skilled in the art will appreciate that the design of the patch830 can be selected as desired for a particular application. The patchcan be made of any biocompatible material with biocompatible adhesiveoperable to hold the weight of the injection device to the skin for apredetermined number of days. The patch design also needs to account forventilation and circulation between the patch and the skin. In oneexample, the patch is a continuous sheet of adhesive material. Inanother example, the patch is a mesh sheet of adhesive materialincluding perforations. In yet another example, the patch is acontinuous sheet of adhesive material with holes cut into the continuoussheet. The holes can align with features of the body of the injectiondevice, such as the cutouts, as desired. The holes can optionally be thesame size as the cutouts. In yet another example, the patch is acontinuous sheet of adhesive material with holes cut into the continuoussheet, and mesh applied across the holes. In yet another example, thepatch can be made of a transparent material to allow the condition ofthe skin around and below the injection device to be monitored. In oneexample, adhesive patches are constructed of pressure sensitiveacrylic-based adhesives with non-woven polyester backings.

Those skilled in the art will further appreciate that the design of thebody of the injection device can be selected as desired for a particularapplication. In one example, the number and position of the cutouts inthe planar deck can be selected to provide ventilation to the skin whilemaintaining sufficient rigidity for the planar deck. In another example,the number and position of the cutouts can be selected to allowobservation of the condition of the skin around and below the injectiondevice. In yet another example, the body of the injection device can bemade of a transparent material to allow the condition of the skin aroundand below the injection device to be monitored. This is particularlyuseful when the patch includes holes or is made from a transparentmaterial. Exemplary materials for the body of the injection deviceinclude polycarbonate, acrylic, or the like. In one embodiment, one ormore optical elements can be molded into the body of the injectiondevice to magnify the area or areas of interest.

FIGS. 21-24 are various embodiments of septums for use in an injectiondevice. The septums can be disposed in the injection device channels. Inone embodiment, the septum is self sealing to block fluid flow throughthe septum after a needle has been put through the septum then removed,preventing fluid flow through the port connected to the channel.

FIG. 21 is a perspective view of one embodiment of an introducer septumfor use in an injection device made in accordance with the invention. Inthis embodiment, the introducer septum is irregular-shaped, i.e., theintroducer septum has an irregular shape. The introducer septum 900includes a number of legs 902 to secure the introducer septum 900 in theintroducer channel.

FIG. 22 is a section view of an injection device made in accordance withthe invention including the introducer septum of FIG. 20. The sectionbisects the introducer port 930 and the injection port 940, and includesthe introducer axis 934 and injection axis 944. The delivery tube 950 isoperably connected to the introducer port 930 and defines an introduceraxis 934, the delivery tube 950 being in fluid communication with theinjection port 940. The introducer port 930 includes an introducerchannel 932, with an introducer port cover 935 and the introducer septum900 disposed in the introducer channel 932. The introducer septum 900 issecured in the introducer channel 932 of the injection device 901 bylegs 902. The injection port 940 includes an injection channel 942defining an injection axis 944 with an injection septum 946 disposed inthe injection channel 942. The injection channel 942 is in fluidcommunication with the delivery tube 950 through a septum connectionchannel 904 in the introducer septum 900. The introducer septum 900 bothconnects the injection port 940 to the delivery tube 950 and fills extraspace within the introducer channel 932 to avoid an unnecessary amountof therapeutic agent from collecting in the introducer channel 932.

FIG. 23 is a perspective view of one embodiment of a septum for use inan injection device made in accordance with the invention. In thisembodiment, the septum is barrel-shaped. The barrel-shape septum 980 canbe used as an introducer septum or an injection septum as desired for aparticular application.

FIGS. 24A & 24B are top side and A-A section views, respectively, of oneembodiment of a septum for use in an injection device made in accordancewith the invention. In this embodiment, the septum is dome-shaped. Thedome septum 990 can be used as an introducer septum or an injectionseptum as desired for a particular application.

FIGS. 25-30 illustrate an on-body injector for use with an injectiondevice made in accordance with the invention. Referring to FIG. 5B, anon-body injector 192 is mateable with the injection port 140 of theinjection device 100 and can be used to deliver a therapeutic agentthrough the injection port 140. The on-body injector 192 can include areservoir to hold the therapeutic agent. In one embodiment, the on-bodyinjector 192 can deliver a basal and/or bolus dose of the therapeuticagent.

FIG. 25 is a perspective view of one embodiment of an on-body injectorfor use with an injection device made in accordance with the invention.The on-body injector 192 includes a housing 1010 to contain the internalcomponents of the on-body injector, a lock 1020 to secure the on-bodyinjector 192 to the injection device, and a fill port 1050 for fillingor refilling the on-body injector 192 with a therapeutic agent for bolusand/or basal injection.

The on-body injector 192 also includes a button 1030 which can be usedto administer a bolus injection. A gap in the bolus injection flow pathprevents bolus injection unless the button 1030 is depressed. The button1030 is operably connected to the bolus injection needle 1040 to slidethe bolus injection needle 1040 along the injection axis. When thebutton 1030 is depressed, the button 1030 advances the bolus injectionneedle tip to close a gap between the bolus injection needle tip and theinjection port of the injection device and to form an injection flowpath to deliver a bolus injection to the patient. The button 1030 alsoadvances a plunger through the bolus reservoir to deliver apredetermined bolus volume to the patient through the injection flowpath once the gap is closed and the injection flow path is complete.Those skilled in the art will appreciate that the button 1030 as definedherein can be any mechanism or combination of mechanisms operable toadvance the bolus injection needle through the gap and deliver the bolusinjection. In one example, the button slides in a track or similarguiding geometry. In another example, the button is a lever that movesthe bolus injection needle and plunger. Those skilled in the art willappreciate that the button can be activated by secondary devices, suchas solenoids, motors, pneumatic activators, or the like.

FIG. 26, in which like elements share like reference numbers with FIG.25, is a partial perspective view of portions of one embodiment of anon-body injector for use with an injection device made in accordancewith the invention. In FIG. 26, the top portion of the housing 1010 hasbeen removed to reveal the interior components. In this embodiment,basal injection is provided by a pressurized reservoir 1070, which is atleast partially filled with a therapeutic agent. The pressurizedreservoir 1070 in this example is a spring coil that at least partiallyuncoils within an interior track 1080 within the housing 1010 when thepressurized reservoir 1070 is pressurized, i.e., when the pressurizedreservoir is at least partially filled with a therapeutic agent. Thepressurized reservoir 1070 can be filled through the fill port 1050. Forbasal injection, the therapeutic agent is delivered through theintroducer port of the injection device, which is in fluid communicationwith the delivery tube of the injection device. The therapeutic agentpasses from the pressurized reservoir 1070, through the flow restrictor1060, and into the patient through the injection device. The flowrestrictor 1060 in this example is tubing having a length and interiordiameter selected to provide a desired pressure drop, supported bytubing support structure 1062. Those skilled in the art will appreciatethat the flow restrictor can be any device providing a pressure dropbetween the pressurized reservoir and the delivery tube as desired for aparticular application. In another example, the flow restrictor can bean orifice. In another example, the flow restrictor can be a bypasschannel that re-directs access to medication. In one embodiment, theflow restrictor can be selected to provide a predetermined basal flowrate, such as a basal flow rate of 20 units of insulin per 24 hours, 30units of insulin per 24 hours, or 40 units of insulin per 24 hours.Those skilled in the art will further appreciate that the pressurizedreservoir can be any device pressurizing the therapeutic agent asdesired for a particular application. In other examples, the pressurizedreservoir can be an elastic bladder, a spring-loaded inelastic bladder,a fluid (gas or liquid) pressurized bladder, or the like.

FIG. 27, in which like elements share like reference numbers with FIGS.25 & 26, is a partial perspective view of portions of one embodiment ofan on-body injector for use with an injection device made in accordancewith the invention. A button spring 1090 provides a bias force to thebutton 1030, to bias the bolus injection needle 1040 away from theinjection port of the injection device and provide the gap between thebolus injection needle tip and the injection port when the button is notdepressed.

FIG. 28, in which like elements share like reference numbers with FIGS.25-27, is a section view of one embodiment of an injection device andon-body injector for use with an injection device made in accordancewith the invention. FIG. 28 illustrates the cross-section of the on-bodyinjector 192 and the injection device 100 divided along the bolusinjection needle 1040.

The bolus injection needle tip 1042 is aligned with the injection septum146 of the injection port 140 along the injection axis 144. The buttonspring 1090 biases the bolus injection needle tip 1042 away from theinjection septum 146 to create a gap 1120 between the bolus injectionneedle tip 1042 and the injection port 140 when the button 1030 is notdepressed. When the button 1030 is depressed, the bolus injection needle1040 slides along the injection axis 144, closing the gap 1120 andinserting the bolus injection needle tip 1042 through the injectionseptum 146. In this example, the bolus injection needle tip 1042 alsopasses through a needle tip septum 1122. Once the bolus injection needletip 1042 has passed through the injection septum 146, and injection flowpath for bolus injection is formed from the bolus reservoir 1100,through the bolus injection needle 1040, through the delivery tube 150,and into the patient. When the button 1030 is released, the bolusinjection needle 1040 slides back to the initial position and the gap1120 is restored. The bolus injection needle tip 1042 is always embeddedwithin a septum (the needle tip septum 1122 or the injection septum 146)to keep the bolus injection needle tip 1042 clean, and to keep the bolusinjection needle tip 1042 capped so no therapeutic agent will leak outof the bolus injection needle tip 1042.

The on-body injector 192 includes a bolus reservoir 1100 with a plunger1110 slideably disposed within the bolus reservoir 1100 and a bolus stop1114 fixed at one end of the bolus reservoir 1100. A bolus spring 1112biases the plunger 1110 away from the bolus stop 1114. The plunger 1110is coupled to the button 1030 so that the plunger 1110 slides throughthe bolus reservoir 1100 when the button 1030 is depressed. The plunger1110 includes a central passage 1116 to allow fluid from the bolusreservoir 1100 to flow through the plunger 1110 into the bolus injectionneedle 1040 and to the patient through the bolus injection needle 1040.The volume of the bolus reservoir 1100 can be selected to provide apredetermined bolus volume to the patient. In one embodiment, thepredetermined bolus volume is 2 units of insulin.

When the plunger 1110 reaches a final position at the end of the bolusreservoir 1100 and contacts the bolus stop 1114, the bolus stop 1114blocks the central passage 1116 in the plunger 1110. Thus, the plunger1110 blocks the injection flow path after the predetermined bolus volumehas been delivered. This prevents additional undesired delivery of atherapeutic agent should the injection flow path remains in place from afailure, such as the bolus injection needle 1040 becoming stuck in theinjection port 140 of the injection device 100, a failure of the button1030 or related mechanism, or the like.

FIG. 29 is a block diagram of one embodiment of an injection device andon-body injector made in accordance with the invention. FIG. 29illustrates the flow paths through the injection device and on-bodyinjector, which can be used for a bolus injection and/or a basalinjection.

Both the bolus injection and basal injection flow paths include anoptional syringe 1302, an optional fill port 1304, a pressure reservoir1306, a delivery tube 1320, supplying the patient 1322. The basalinjection flow path also includes a flow restrictor 1308 and anintroducer port 1310 between the pressure reservoir 1306 and thedelivery tube 1320. The bolus injection flow path also includes a bolusreservoir 1312, a bolus injection needle 1314, a gap 1316, an injectionport 1318 between the pressure reservoir 1306 and the delivery tube1320.

The optional syringe 1302 can be inserted in the optional fill port 1304to fill or refill the pressure reservoir 1306. As illustrated by thedashed line between the optional syringe 1302 and the optional fill port1304, the optional syringe 1302 is not permanently attached to theoptional fill port 1304 and can be removed. In one embodiment, thepressure reservoir 1306 can be pre-filled with a therapeutic agent whenthe on-body injector is delivered to the patient, so that the fill port1304 is used for refilling the pressure reservoir 1306. In anotherembodiment, the pressure reservoir 1306 is empty when the on-bodyinjector is delivered to the patient, so that the fill port 1304 is usedfor initially filling the pressure reservoir 1306. In yet anotherembodiment, the optional fill port 1304 is omitted and the on-bodyinjector is a single use device with the pressure reservoir 1306pre-filled with a therapeutic agent. Those skilled in the art willappreciate that the optional syringe 1302 can be any device operable todeliver a therapeutic agent into the fill port 1304 as desired for aparticular application.

For basal injection, the pressure reservoir 1306 of the on-body injectorprovides the therapeutic agent through the flow restrictor 1308 of theon-body injector to the introducer port 1310 of the injection device.The delivery tube 1320 of the injection device applies the therapeuticagent to the patient 1322. The flow restrictor 1308 can be any deviceproviding a pressure drop between the pressurized reservoir and thedelivery tube as desired for a particular application. In one example,the flow restrictor can be tubing having a length and interior diameterselected to provide a desired pressure drop. In another example, theflow restrictor can be an orifice. In another example, the flowrestrictor can be a bypass channel that re-directs access to medication.In one embodiment, the flow restrictor can be selected to provide apredetermined basal flow rate, such as a basal flow rate of 20 units ofinsulin per 24 hours, 30 units of insulin per 24 hours, or 40 units ofinsulin per 24 hours.

For bolus injection, the pressure reservoir 1306 of the on-body injectorfills the bolus reservoir 1312 of the on-body injector with therapeuticagent. The on-body injector delivers a predetermined bolus volume (thevolume of the pressure reservoir 1306) when the patient depresses abutton. When the button is depressed, the tip of the bolus injectionneedle 1314 closes the gap 1316 between the bolus injection needle 1314of the on-body injector and enters the injection port 1318 of theinjection device to complete the bolus injection flow path. The gap 1316as illustrated by the dashed lines between the bolus injection needle1314 of the on-body injector and the injection port 1318 of theinjection device is present when the button is not depressed to preventbolus injection unless the button is depressed. Depressing the buttonalso delivers the therapeutic agent from the bolus reservoir 1312,through the bolus injection needle 1314, through the injection port1318, through the delivery tube 1320, and into the patient 1322. In oneembodiment, the predetermined bolus volume is 2 units of insulin. Thebolus injection flow path can optionally include a flow blocker (such asthe bolus stop 1114 of FIG. 28, for example) which blocks the bolusinjection flow path after the predetermined bolus volume has beendelivered.

Referring to FIG. 29, for one embodiment of an on-body injector for abolus injection, the injection device has an injection port 1318 influid communication with a delivery tube 1320 with the injection port1318 lying on an injection axis. The on-body injector includes a bolusreservoir 1312; a bolus injection needle 1314 in fluid communicationwith the bolus reservoir 1312, the bolus injection needle 1314 having abolus injection needle tip aligned with the injection port 1318, thebolus injection needle 1314 being slideably biased away from theinjection port to define a gap 1316 between the bolus injection needletip and the injection port 1318; and a button operably connected to thebolus injection needle 1314 to slide the bolus injection needle 1314along the injection axis. The button is operable to advance the bolusinjection needle tip to close the gap 1316 and advance the bolusinjection needle tip into the injection port 1318 to form an injectionflow path from the bolus reservoir 1312, through the bolus injectionneedle 1314, through the delivery tube 1320, and into the patient 1322.The button is further operable to advance a plunger through the bolusreservoir 1312 to deliver a predetermined bolus volume to the patient1322 through the injection flow path.

For one embodiment of an on-body injector for a basal injection, theinjection device has an introducer port 1310 in fluid communication witha delivery tube 1320. The on-body injector includes a pressurizedreservoir 1306; a flow restrictor 1308 disposed between the pressurizedreservoir 1306 and the delivery tube 1320, the flow restrictor 1308being tubing having a length and interior diameter selected to provide adesired pressure drop; and a fill port 1304 in fluid communication withthe pressurized reservoir.

FIG. 30 is a flow chart of a method of use for an on-body injector inaccordance with the invention. The method 1400 is a method of use for anon-body injector with an injection device for delivering a predeterminedbolus volume to a patient. The method 1400 includes deploying theinjection device 1410 in the patient, the injection device having adelivery tube placed in the patient and an injection port in fluidcommunication with the delivery tube; securing the on-body injector tothe injection device 1420, the on-body injector having a bolus injectionneedle aligned with and spaced apart from the injection port; depressinga button on the on-body injector to advance the bolus injection needle1430 into the injection port; and further depressing the button todeliver the predetermined bolus volume 1440 from the on-body injectorthrough the bolus injection needle, through the delivery tube, and intothe patient. The method 1400 can further include releasing the button toretract the bolus injection needle from the injection port.

The method 1400 can also include delivering a basal injection. In thisembodiment, the injection device further includes an introducer port influid communication with the delivery tube, and the on-body injectorfurther includes a pressurized reservoir in fluid communication with abasal injection needle inserted in the introducer port. The method 1400further includes delivering a basal injection from the pressurizedreservoir through the basal injection needle, through the delivery tube,and into the patient. the on-body injector can further include a fillport in fluid communication with the pressurized reservoir, in whichcase the method 1400 can further include delivering a therapeutic agentthorough the fill port into the pressurized reservoir.

FIGS. 31-38 illustrate an electronic injector for use with an injectiondevice or for independent use. The electronic injector uses aMicro-Electro-Mechanical System (MEMS) pump to deliver a therapeuticagent from a reservoir to a patient.

FIG. 31 is a block diagram of one embodiment of an injection device andelectronic on-body injector made in accordance with the invention. FIG.31 illustrates the flow paths through and electrical signals for theinjection device and electronic on-body injector, which can be used fora bolus injection and/or a basal injection. The injection device isdeployed in the patient with a delivery tube placed subcutaneously andthe electronic on-body injector is secured to the injection device.

The basal injection flow path includes a fluid reservoir 1602, a MEMSpump 1604, and a delivery tube 1606 supplying the patient 1608. Thebolus injection flow path includes the fluid reservoir 1602, the MEMSpump 1604, a bolus injection needle 1610, a gap 1612, an injection port1614, and the delivery tube 1606 supplying the patient 1608. The bolusinjection mechanism also includes a bolus needle button 1616 operable toadvance the bolus injection needle 1610 and to activate the MEMS pump1604 to deliver a predetermined bolus volume.

The electronic portion of the electronic on-body injector includes abattery 1620, a regulator 1622, and a microcontroller 1624. The battery1620 has a DC power output 1621 which is provided to the regulator 1622.The battery 1620 is also operably connected (not shown) to provide powerto the microcontroller 1624. The regulator 1622 is operably connected tothe battery 1620 to convert the DC power output 1621 to a pump drivesignal 1623 in response to a regulator control signal 1625 from themicrocontroller 1624. The regulator 1622 provides the pump drive signal1623 to the MEMS pump 1604. The pump drive signal 1623 can be a basalpump drive signal or a bolus pump drive signal as required. The MEMSpump 1604 is responsive to the pump drive signal 1623 to control flow ofthe fluid from the fluid reservoir 1602, through the MEMS pump 1604,through the delivery tube 1606, and into the patient 1608.

The microcontroller 1624 controls the electronic on-body injector. Themicrocontroller 1624 receives a bolus needle button signal 1617 from thebolus needle button 1616, which activates MEMS pump 1604 to deliver apredetermined bolus volume to the patient through the bolus injectionflow path. The microcontroller 1624 provides the regulator controlsignal 1625 to the regulator 1622, controlling the pump drive signal1623. The microcontroller 1624 can also optionally be responsive to acontrol switch signal 1627 from a control switch 1626 and/or can providea display signal 1629 to a display 1628. The control switch 1626 and thedisplay 1628 can be used to provide input and output, respectively, tothe electronic on-body injector. For example, the display 1628 can beused to display injection options, such as the basal injection rate, andcontrol switch 1626 can be used to select one of the injection options.The microcontroller 1624 can also include or be associated with memoryto store data and/or instructions. The microcontroller 1624 can also beoperably connected to one or more sensors to monitor the patient 1608and/or a wireless interface to communicate with one or more externalsensors monitoring the patient 1608 or external communication and/orcontrol systems, such as the internet, a continuous glucose monitoringsystem, a mobile device, or the like. Exemplary uses for a wirelessinterface providing communication between the electronic injector and anexternal system/device include calculating/setting dosages, trackinginjection times and volumes, and/or sending reminders to a paired device(computer, phone, tablet, mobile device, or the like).

For basal injection, the fluid reservoir 1602 of the on-body injectorprovides the therapeutic agent to the patient 1608 through the basalinjection flow path (the fluid reservoir 1602, MEMS pump 1604, anddelivery tube 1606). In one embodiment, the patient 1608 initiates thebasal injection by pressing the control switch 1626, which provides thecontrol switch signal 1627 to the microcontroller 1624, which providesthe regulator control signal 1625 to the regulator 1622. In this case,the regulator control signal 1625 is a basal regulator control signaland the regulator 1622 generates the pump drive signal 1623 as a basalpump drive signal. The MEMS pump 1604 delivers the desired basalinjection to the patient 1608 in response to the basal pump drivesignal. In another embodiment, the patient 1608 selects a desired basalflow rate using the control switch 1626 and the display 1628 beforeinitiating the basal injection. Exemplary basal flow rates can include20 units of insulin per 24 hours, 30 units of insulin per 24 hours, 40units of insulin per 24 hours, or the like.

For bolus injection, the fluid reservoir 1602 of the on-body injectorprovides the therapeutic agent to the patient 1608 through the bolusinjection flow path (the fluid reservoir 1602, MEMS pump 1604, bolusinjection needle 1610, gap 1612, injection port 1614, and delivery tube1606). The on-body injector delivers a predetermined bolus volume whenthe patient depresses the bolus needle button 1616 by activating theMEMS pump 1604 at a predetermined flow rate for a predeterminedduration. When the bolus needle button 1616 is depressed, the tip of thebolus injection needle 1610 closes the gap 1612 between the bolusinjection needle 1610 of the on-body injector and enters the injectionport 1614 of the injection device to complete the bolus injection flowpath. The gap 1612 as illustrated by the dashed lines between the bolusinjection needle 1610 of the on-body injector and the injection port1614 of the injection device is present when the bolus needle button1616 is not depressed to prevent bolus injection unless the bolus needlebutton 1616 is depressed. Depressing the bolus needle button 1616 alsodelivers the bolus needle button signal 1617 to the microcontroller1624, which provides the regulator control signal 1625 to the regulator1622. In this case, the regulator control signal 1625 is a bolusregulator control signal and the regulator 1622 generates the pump drivesignal 1623 as a bolus pump drive signal. The MEMS pump 1604 deliversthe predetermined bolus volume to the patient 1608 in response to thebolus pump drive signal. In one embodiment, the bolus needle button 1616triggers a switch in the path of button mechanism travel which startsthe bolus injection when the bolus injection flow path is complete. Inone example, the predetermined bolus volume is 2 units of insulin. Inanother embodiment, the patient 1608 selects a desired predeterminedbolus volume using the control switch 1626 and the display 1628 beforeinitiating the bolus injection. In this example, the basal and bolusdrugs are the same drug, coming from the same fluid reservoir 1602 andgoing through the same flow path, but administered at different rates.The basal injection flows constantly at a very low rate. When a bolusinjection is requested, the regulator 1622 changes the pump drive signal1623 from the basal pump drive signal to a bolus delivery signal. Whenthe bolus delivery is complete, the regulator 1622 changes the pumpdrive signal 1623 from the bolus pump drive signal to the basal deliverysignal and basal injection resumes. In other embodiments, the basalinjection flow path can include an orifice, check valve, or be sized sothat the fluid does not flow forward or backward through the basalinjection flow path during bolus injection.

The electronic on-body injector can optionally include a fill port (notshown) to fill or refill the fluid reservoir 1602. In one embodiment,the fluid reservoir 1602 can be pre-filled with a therapeutic agent whenthe on-body injector is delivered to the patient, so that the fill portis used for refilling the fluid reservoir 1602. In another embodiment,the fluid reservoir 1602 is empty when the electronic on-body injectoris delivered to the patient, so that the fill port is used for initiallyfilling the fluid reservoir 1602. In yet another embodiment, the fillport is omitted and the electronic on-body injector is a single usedevice with the fluid reservoir 1602 pre-filled with a therapeuticagent.

For one embodiment of an electronic on-body injector for a bolusinjection for use with a patient 1608 to deliver a fluid through aninjection device, the injection device has an injection port 1614 influid communication with a delivery tube 1606 with the injection port1614 lying on an injection axis. The electronic on-body injectorincludes a fluid reservoir 1602 operable to hold the fluid; a MEMS pump1604 in fluid communication with the fluid reservoir 1602; a bolusinjection needle 1610 in fluid communication with the MEMS pump 1604,the bolus injection needle 1610 having a bolus injection needle tipaligned with the injection port, the bolus injection needle 1610 beingslideably biased away from the injection port to define a gap 1612between the bolus injection needle tip and the injection port; and abolus needle button 1616 operably connected to the bolus injectionneedle 1610 to slide the bolus injection needle 1610 along the injectionaxis. the bolus needle button 1616 is operable to advance the bolusinjection needle tip to close the gap 1612 and advance the bolusinjection needle tip into the injection port to form a bolus injectionflow path from the fluid reservoir 1602, through the MEMS pump 1604,through the bolus injection needle 1610, through the delivery tube 1606,and into the patient 1608. The bolus needle button 1616 is furtheroperable to activate the MEMS pump 1604 to deliver a predetermined bolusvolume to the patient 1608 through the bolus injection flow path inresponse to a bolus pump drive signal.

The electronic on-body injector for bolus injection can also include abattery 1620 having a DC power output 1621; a regulator 1622 operablyconnected to the battery 1620 to convert the DC power output 1621 to thebolus pump drive signal in response to a regulator control signal 1625;and a microcontroller 1624 operably connected to the regulator 1622 toprovide the regulator control signal 1625. The MEMS pump 1604 isresponsive to the bolus pump drive signal to control flow of the fluidfrom the MEMS pump 1604 through the bolus injection flow path.

For one embodiment of an electronic on-body injector for a basalinjection for use with a patient 1608 to deliver a fluid through aninjection device, the injection device has a delivery tube 1606. Theelectronic on-body injector includes a fluid reservoir 1602 operable tohold the fluid; and a MEMS pump 1604 in fluid communication with thefluid reservoir 1602 and the delivery tube 1606 to form a basalinjection flow path from the fluid reservoir 1602, through the MEMS pump1604, through the delivery tube 1606, and into the patient 1608. TheMEMS pump 1604 is operable to deliver a basal injection to the patient1608 through the basal injection flow path in response to a basal pumpdrive signal.

The electronic on-body injector for basal injection can also include abattery 1620 having a DC power output 1621; a regulator 1622 operablyconnected to the battery 1620 to convert the DC power output 1621 to thebasal pump drive signal in response to a regulator control signal 1625;and a microcontroller 1624 operably connected to the regulator 1622 toprovide the regulator control signal 1625. The MEMS pump 1604 isresponsive to the basal pump drive signal to control flow of the fluidfrom the MEMS pump 1604 through the basal injection flow path. Exemplarybatteries 1620 include non-rechargeable alkaline batteries rechargeablelithium-ion batteries, rechargeable lithium ion polymer batteries, andthe like. In one example, the battery capacity is in the range of200-500 mAh, In one example, the battery dimensions are 15×40×5 mm.Those skilled in the art will appreciate that the battery type,capacity, and size can be selected as desired for a particularapplication. Exemplary microcontrollers 1624 include the CC2541(Bluetooth/microprocessor combination) from Texas Instruments, PSoC® 4(microcontroller) from Cypress Semiconductor Corporation, or the like.Those skilled in the art will appreciate that the microcontrollers canbe selected as desired for a particular application.

FIGS. 32A-32C are wave form diagrams of bolus, basal, and basal pumpdrive signals, respectively, for an electronic injector made inaccordance with the invention. The frequency, amplitude, and duration ofthe AC portion of the pump drive signal determine the amount of fluidwhich is injected.

The bolus pump drive signal is selected to provide a predetermined bolusvolume from the MEMS pump in response to a single bolus injectionrequest from a patient. Referring to the example of FIG. 32A, the boluspump drive signal 1700 includes an AC power signal 1710 for apredetermined duration 1720 between time T1 when the patient requests abolus injection until the time T2 when the predetermined bolus volumehas been delivered. The bolus pump drive signal 1700 has a value of 0 VDC before and after the AC power signal 1710. The MEMS pump moves thefluid when the AC power signal 1710 is active. In this example, the ACpower signal 1710 is a sine wave. Those skilled in the art willappreciate that the pump drive signal can have any AC waveform asdesired for a particular application. For example, the AC waveform canbe a sine wave, a saw tooth wave, a square wave, or the like.

The basal pump drive signal is selected to provide a desired basal flowrate from the MEMS pump. Referring to the example of FIG. 32B, the basalpump drive signal 1730 includes a series of AC power signals 1740 of ACpower duration 1742 alternating with zero volt power signals 1750 ofzero volt power duration 1752. The time of AC power duration 1742 and/or0 V power duration 1752 can be selected to provide the desired basalflow rate. The MEMS pump moves the fluid when each of the AC powersignals 1740 is active. In this example, the AC power signal 1740 is asine wave. Those skilled in the art will appreciate that the pump drivesignal can have any AC waveform as desired for a particular application.For example, the AC waveform can be a sine wave, a saw tooth wave, asquare wave, or the like.

FIG. 32C is an example of a continuous basal pump drive signal, whichprovides a continuous AC waveform. The basal pump drive signal 1760 hasa frequency and/or amplitude which is substantially less than the ACpower signal of FIG. 32A or FIG. 32B, so that the basal pump drivesignal 1760 is continuously applied to the MEMS pump to provide adesired basal flow rate from the MEMS pump. In this example of FIG. 32C,the basal pump drive signal 1760 is a sine wave. Those skilled in theart will appreciate that the basal pump drive signal can have any ACwaveform as desired for a particular application. For example, the basalpump drive signal can be a sine wave, a saw tooth wave, a square wave,or the like.

FIGS. 33A-33C, in which like elements share like reference numbers, areschematic diagrams of a piezoelectric MEMS pump for use in an electronicinjector made in accordance with the invention. FIG. 33A illustrates theMEMS pump at rest, FIG. 33B illustrates the MEMS pump during fluidintake, and FIG. 33C illustrates the MEMS pump during fluid output.

Referring to FIG. 33A illustrating the MEMS pump at rest, thepiezoelectric MEMS pump 1800 includes a case 1810 defining a workingchamber 1820, the working chamber 1820 having a piezoelectric wall 1830responsive to a first pump drive signal voltage and a second pump drivesignal voltage; a one way inlet valve 1840 operable to permit flow ofthe fluid into the working chamber 1820 and to block reverse flow of thefluid from the working chamber 1820; and a one way outlet valve 1850operable to permit flow of the fluid from the working chamber 1820 andto block reverse flow of the fluid into the working chamber 1820. Theone way inlet valve 1840 is in fluid communication with the fluidreservoir (not shown). When the piezoelectric MEMS pump 1800 is used forbolus injection, the one way outlet valve 1850 is in fluid communicationwith the bolus injection needle (not shown). When the piezoelectric MEMSpump 1800 is used for basal injection, the one way outlet valve 1850 isin fluid communication with the delivery tube (not shown). In oneembodiment, the piezoelectric wall 1830 includes a piezoelectric disk1832 with a membrane 1834 sealing the working chamber 1820. The workingchamber 1820 can be etched directly out of the silicon base material.The flexible membrane 1834 can be a thin layer of silicon or silicondioxide. The piezoelectric disk 1832 can be attached to the flexiblemembrane 1834.

Referring to FIG. 33B illustrating the MEMS pump during fluid intake,the piezoelectric wall 1830 flexes outward to increase volume of theworking chamber 1820 in response to the first pump drive signal voltage(+V to ground across the piezoelectric wall 1830) to draw the fluidthrough the one way inlet valve to the working chamber 1820 as indicatedby the arrow 1842.

Referring to FIG. 33C illustrating the MEMS pump during fluid output,the piezoelectric wall 1830 flexes inward to decrease the volume of theworking chamber 1820 in response to the second pump drive signal voltage(−V to ground across the piezoelectric wall 1830) to force the fluidfrom the working chamber 1820 through the one way outlet valve 1850 asindicated by the arrow 1852.

Alternately applying the first pump drive signal voltage and the secondpump drive signal voltage causes the piezoelectric wall 1830 tooscillate, pumping fluid through the piezoelectric MEMS pump 1800. Inone embodiment, the first pump drive signal voltage and the second pumpdrive signal voltage are applied as a pump drive signal as a squarewave. The piezoelectric MEMS pump 1800 can be fabricated using standardsemiconductor techniques, resulting in a pump of reduced size andimproved accuracy compared to standard mechanical pumps. In one example,the piezoelectric MEMS pump 1800 can deliver flow rates up to 3milliliters per minute, which is the equivalent of 300 units of insulinper minute or 5 units of insulin per second. Those skilled in the artwill appreciate that the MEMS pump is not limited to a piezoelectricMEMS pump, but can be a bimetallic pump, an electrostatic pump, athermopneumatic pump, an electromagnetic pump, a phase change pump, orthe like, as desired for a particular application.

FIGS. 34A-34C, in which like elements share like reference numbers, arean exploded perspective view, a partial perspective view, and a partialperspective view of an injection device and electronic on-body injectormade in accordance with the invention. In this embodiment, theelectronic on-body injector is the electronic injector.

Referring to FIG. 34A, the electronic on-body injector 1900 isillustrated separated from the injection device 1910. The electronicon-body injector 1900 has a housing 1902 to contain the internalcomponents of the electronic on-body injector 1900. The injection device1910 has an injection port 1912 lying on an injection axis 1914 asillustrated by the dashed line. The injection device 1910 in thisexample also has an introducer port 1916.

Referring to FIG. 34B, which illustrates the electronic on-body injector1900 with the top of the housing 1902 removed, the interior of thehousing 1902 of the electronic on-body injector 1900 encloses thebattery 1920, the regulator 1922, the microcontroller 1924, the fluidreservoir 1926, and the MEMS pump 1928. The bolus injection needle 1930is partially enclosed within the housing 1902 with the bolus injectionneedle tip 1932 extending from the housing 1902 to access the injectiondevice. Various controls and indicators (not shown), such as the bolusneedle button, control switches, displays, and the like, can extendthrough and/or be positioned upon the housing 1902. FIG. 34C illustratesthe electronic on-body injector 1900 in place on the injection device1910. The bolus injection needle (not shown) is aligned with theinjection axis 1914 of the injection device 1910.

FIG. 35 is a block diagram of one embodiment of an electronic injectormade in accordance with the invention. FIG. 35 illustrates the flowpaths through and electrical signals for the electronic injector, whichcan be used for injection of a therapeutic agent.

The basal injection flow path includes a fluid reservoir 2002, a MEMSpump 2004, a needle fitting 2006, and an injection needle 2007 supplyingthe patient 2008. In one embodiment, the injection needle 2007 isdetachable from the needle fitting 2006 so that the injection needle2007 can be replaced at a desired frequency, e.g., after each injection.In another embodiment, the injection needle 2007 is permanently attachedto the needle fitting 2006. In yet another embodiment, no injectionneedle is used, but the tip of the electronic injector is adapted foruse as a needleless pen injector as described in conjunction with FIGS.11 & 12 above.

Referring to FIG. 35, the electronic portion of the electronic injectorincludes a battery 2020, a regulator 2022, and a microcontroller 2024.The battery 2020 has a DC power output 2021 which is provided to theregulator 2022. The battery 2020 is also operably connected (not shown)to provide power to the microcontroller 2024. The regulator 2022 isoperably connected to the battery 2020 to convert the DC power output2021 to a pump drive signal 2023 in response to a regulator controlsignal 2025 from the microcontroller 2024. The regulator 2022 providesthe pump drive signal 2023 to the MEMS pump 2004. The MEMS pump 2004 isresponsive to the pump drive signal 2023 to control flow of the fluidfrom the fluid reservoir 2002, through the MEMS pump 2004, through theneedle fitting 2006, through the needle 2007, and into the patient 2008.In one embodiment, the MEMS pump 2004 is a piezoelectric MEMS pump asdescribed in conjunction with FIGS. 33A-33C above. In other embodiments,the MEMS pump 2004 can be a bimetallic pump, an electrostatic pump, athermopneumatic pump, an electromagnetic pump, a phase change pump, orthe like, as desired for a particular application.

Referring to FIG. 35, the microcontroller 2024 controls the electronicinjector. The microcontroller 2024 provides the regulator control signal2025 to the regulator 2022, controlling the pump drive signal 2023. Themicrocontroller 2024 can be responsive to a control switch signal 2027from a control switch 2026 and/or can provide a display signal 2029 to adisplay 2028. The control switch 2026 and the display 2028 can be usedto provide input and output, respectively, to the electronic injector.For example, the display 2028 can be used to display injection options,such as the bolus injection volume, and control switch 2026 can be usedto select one of the injection options. The microcontroller 2024 canalso include or be associated with memory to store data and/orinstructions. The microcontroller 2024 can also be operably connected toone or more sensors to monitor the patient 2008 and/or a wirelessinterface to communicate with one or more external sensors monitoringthe patient 2008 or external communication and/or control systems, suchas the internet, a continuous glucose monitoring system, a mobiledevice, or the like. Exemplary uses for a wireless interface providingcommunication between the electronic injector and an externalsystem/device include calculating/setting dosages, tracking injectiontimes and volumes, and/or sending reminders to a paired device(computer, phone, tablet, mobile device, or the like).

For bolus injection, the fluid reservoir 2002 of the on-body injectorprovides the therapeutic agent to the patient 2008 through the injectionflow path (the fluid reservoir 2002, MEMS pump 2004, needle fitting2006, and injection needle 2007). In one embodiment, the patient 2008initiates a bolus injection by pressing the control switch 2026, whichprovides the control switch signal 2027 to the microcontroller 2024,which provides the regulator control signal 2025 to the regulator 2022.In this case, the regulator control signal 2025 is a bolus regulatorcontrol signal and the regulator 2022 generates the pump drive signal2023 as a bolus pump drive signal. The MEMS pump 2004 delivers thedesired bolus injection to the patient 2008 in response to the boluspump drive signal. In another embodiment, the patient 2008 selects apredetermined bolus volume using the control switch 2026 and the display2028 before initiating the bolus injection. In one example, thepredetermined bolus volume is 2 units of insulin.

The electronic injector can optionally include a fill port (not shown)to fill or refill the fluid reservoir 2002. In one embodiment, the fluidreservoir 2002 can be pre-filled with a therapeutic agent when theon-body injector is delivered to the patient, so that the fill port isused for refilling the fluid reservoir 2002. In another embodiment, thefluid reservoir 2002 is empty when the electronic injector is deliveredto the patient, so that the fill port is used for initially filling thefluid reservoir 2002. In yet another embodiment, the fill port isomitted and the electronic injector is a single use device with thefluid reservoir 2002 pre-filled with a therapeutic agent.

For one embodiment of an electronic injector for use with a patient 2008to deliver a fluid, the electronic injector includes a fluid reservoir2002 operable to hold the fluid; a MEMS pump 2004 in fluid communicationwith the fluid reservoir 2002; a needle fitting 2006 adapted to receivean injection needle, the needle fitting 2006 being in fluidcommunication with the MEMS pump 2004; a battery 2020 having a DC poweroutput 2021; a regulator 2022 operably connected to the battery 2020 toconvert the DC power output 2021 to a pump drive signal 2023 in responseto a regulator control signal 2025; a microcontroller 2024 operablyconnected to the regulator 2022 to provide the regulator control signal2025; and a housing to enclose the battery 2020, the regulator 2022, themicrocontroller 2024, the fluid reservoir 2002, and the MEMS pump 2004.The MEMS pump 2004 is responsive to the pump drive signal 2023 tocontrol flow of the fluid from the fluid reservoir 2002, through theMEMS pump 2004, through the injection needle 2007, and into the patient2008.

FIGS. 36A-36D, in which like elements share like reference numbers, area perspective view, a top view, a side view, and a partial perspectiveview of an electronic injector made in accordance with the invention. Inthis example, the electronic injector has a pen form factor, which inthis example has a length less than or equal to 125 mm, a width lessthan or equal to 20 mm, and a height less than or equal to 9 mm.

Referring to FIGS. 36A-36C, the electronic injector 2100 has a housing2102 to contain the internal components of the electronic injector 2100.The injection needle 2130 is attached to the electronic injector 2100 atthe needle fitting 2132. In this example, the electronic injector 2100also includes a cap 2104 removeable from the housing 2102. In oneembodiment, the housing 2102 can include a control switch (not shown)which can be used to initiate an injection.

Referring to FIG. 36D, which illustrates the electronic injector 2100with a portion of the housing 2102 removed, the interior of the housing2102 of the electronic injector 2100 encloses the battery 2120, theregulator 2122, the microcontroller 2124, the fluid reservoir 2126, andthe MEMS pump 2128. Various controls and indicators (not shown), such ascontrol switches, displays, and the like, can extend through and/or bepositioned upon the housing 2102.

FIGS. 37A-37E, in which like elements share like reference numbers, area perspective view, a top view, a side view, an exploded perspectiveview, and a partial top view of an electronic injector made inaccordance with the invention. In this example, the electronic injectorhas a card form factor, which in this example has a length less than orequal to 85 mm, a width less than or equal to 55 mm, and a height lessthan or equal to 8 mm.

Referring to FIGS. 37A-37C, the electronic injector 2200 has a housing2202 to contain the internal components of the electronic injector 2200.The injection needle 2230 can be attached to the electronic injector2200 at the needle fitting 2232.

Referring to FIGS. 37D & 37E, which illustrate the electronic injector2200 with a top portion of the housing 2202 removed, the interior of thehousing 2202 of the electronic injector 2200 encloses the battery 2220,the regulator 2222, the microcontroller 2224, the fluid reservoir 2226,and the MEMS pump 2228. Various controls and indicators (not shown),such as control switches, displays, and the like, can extend throughand/or be positioned upon the housing 2202.

FIG. 38 is a schematic cross section view of an electronic injector madein accordance with the invention. The electronic injector includes anadhesive patch operable to secure the housing to the patient.

The electronic injector 2300 has a housing 2302 to contain the internalcomponents of the electronic injector 2300. The injection needle 2330protrudes through the adhesive strip 2304, which forms the bottom of thehousing 2302 for adhesively attaching the electronic injector 2300 tothe patient. The interior of the housing 2302 of the electronic injector2300 encloses the battery 2320, the regulator 2322, the microcontroller2324, the fluid reservoir 2326, and the MEMS pump 2328. Various controlsand indicators (not shown), such as control switches, displays, and thelike, can extend through and/or be positioned upon the housing 2302. Inone embodiment, the electronic injector 2300 includes a push button 2332which can be used to initiate delivery of a therapeutic agent to thepatient.

The electronic injector as described in conjunction with FIGS. 31-38above can be extended to include additional features for convenience,ease-of-use, and safety.

The electronic injector can include wireless functionality, allowingcommunication with local or remote communication devices. Examples ofwireless connections include Bluetooth, Bluetooth Low Energy, Near FieldCommunication or 802.11 Wi-Fi, and the like. This wireless communicationcan be used to pull injection data from the electronic injector and tointerface with the electronic injector, including inputting data tocalculate injection dosages, directly inputting injection dosages,setting timers, reminders, and safety lockouts. In one embodiment, theelectronic injector can be paired with an on-body continuous glucosemonitor to calculate the desired bolus injection volume for theelectronic injector and avoid manual entry. In this embodiment, both theContinuous Glucose Monitor (CGM) and the injector can be paired with awireless device running a control application. The wireless device canread in the current glucose level of the patient from the CGM and thepatient can manually enter their weight/insulin resistance information(which can be saved for future use and updated as needed) along withtheir intended sugar intake. the mobile device control application canthen calculate the injection volume and send that information back tothe electronic injector. In this embodiment, neither the electronicinjector nor the CGM has the computational capability to do thiscalculation. In another embodiment, the CGM can connect directly to theelectronic injector. The patient can perform an initial step of loadingin their weight and treatment resistance information. During normal use,the patient would only enter the amount of food they plan to consume.The electronic injector can then calculate the correct dosage for thepatient. In another embodiment, the electronic injector can wirelesslyconnect to the CGM to read the patient's current glucose levels, thencan take direct patient input on incoming sugars. The electronicinjector can then perform the dosage calculation with no other wirelessdevice involved. In another embodiment, the electronic injector can bepaired with a communication device (computer, phone, tablet, etc.) whichtracks usage data obtained by the electronic injector. Exemplary datainclude tracking of injection times and injection amounts, which can beused to establish trends and/or to verify that proper injectionsoccurred at proper times. Such tracking could be particularly useful incaring for the young and the elderly. In yet another embodiment, theelectronic injector can obtain and/or provide data to remote medicaldatabases, such as the Medtronic CareLink Network, to provide an easyand quick interface between the patient and physician in an effort tocontinuously manage the patient's treatment. This would be particularlyuseful for new patients that need to make frequent adjustments to theirdosage until the patient and doctor determine the correct dosages touse.

The electronic injector can also include safety features. In oneembodiment, the electronic injector can remind the patient when it isthe proper time for a basal injection by use of a vibration, auditory,and/or visual signal at a preset or predetermined time. The electronicinjector can also verify that injections occur at the proper injectiontime with the proper injection amount, and provide the data to remotemedical databases or control applications over a paired communicationdevice. In another embodiment, the electronic injector can provide awarning or injection lockout when a second injection is attempted withina certain time period, preventing accidental double injections. In yetanother embodiment when the therapeutic agent is provided in areplaceable reservoir, the electronic injector can detect the type ofreplaceable reservoir and/or recognize the type of insulin or othertherapeutic agent being used, and adjust the operation of the electronicinjector automatically. Each reservoir can have a unique ID tag, whichcan take the form of an RFID tag, EEPROM, a variable resistance, a smalloptical tag, or the like, that the electronic injector can scan toidentify the specific reservoir type, contents, and/or expiration date.

The electronic injector can also include device monitoring features. Inone embodiment, the electronic injector can verify the flow rate of thetherapeutic agent using a MEMS flow meter to assure that it is correct.When the flow rate is too high, the electronic injector can stop theinjection to avoid an excessive delivery of the therapeutic agent. Whenthe flow rate is too low, the electronic injector can stop the pump toavoid build up of excessive delivery pressure due to an obstruction inthe flowpath, such as a kink in the tubing. In either situation, theelectronic injector can send a warning to the patient via a vibration,auditory signal, and/or visual signal through either the electronicinjector or paired mobile device indicating that the injection hasstopped. In another embodiment, the electronic injector can have atemperature sensor that monitors the temperature of the therapeuticagent within the reservoir. When the therapeutic agent temperature risesabove or falls below recommended thresholds, the electronic injector canwarn the patient via a vibration, auditory signal, and/or visual signalthat the therapeutic agent may no longer be safe to use. In anotherembodiment, the electronic injector can provide a low battery warning towarn the patient that the electronic injector may not be available forservice. This warning can be a vibration, auditory signal, and/or visualsignal. This warning can also pop up as a warning, such as a vibration,auditory signal, and/or visual signal, on a wirelessly connected mobiledevice. In yet another embodiment, the electronic injector can check theidentity and/or the expiration date of the therapeutic agent when thetherapeutic agent is provided in a replaceable reservoir. Thisinformation can be included in the unique ID tag described above.

The electronic injector can also include green technology features. Inone embodiment, the electronic injector can harvest energy to rechargeor replace the battery. The electronic injector can turn mechanicalmotion (button press, body motions) into electrical energy through apiezo energy harvesting module. In another embodiment, the electronicinjector can use rechargeable batteries that can be recharged via an ACwall adapter, or a USB, mini USB or micro USB connector.

The electronic injector can also include therapeutic agent flexibilityfeatures. The electronic injector can work with existing therapeuticagents and new therapeutic agent coming onto the market. Along withinsulin for diabetes treatment, the electronic injector can work withglucagon-like peptide-1 (GLP-1) or Amylin pancreatic hormone. Theelectronic injector can also be used with other therapeutic agents suchas injectable pain medication, steroids, Botox, or the like. In oneembodiment, the electronic injector can adapt operation to provide amaximum flow rate and/or lockout timer through internal control valvesand utilizing a clock timer within the electronic injector to preventabuse of the therapeutic agent. In one embodiment, the electronicinjector can include dual reservoirs so that one electronic injector canprovide different therapeutic agents to a patient requiring more thanone type of therapeutic agent. In one example, one reservoir can housefast acting bolus insulin, e.g., Novolog, and the other reservoir canhouse slow acting basal insulin, e.g., Lantix.

The electronic injector can include convenience features to encouragethe patient to use the device. In one embodiment, the electronicinjector would be disposable with all the parts being prepackaged(including the therapeutic agent in the reservoir) and would be tossedaway as soon as the therapeutic agent is used up or expires. In anotherembodiment, the electronic injector would be durable with a replaceablecartridge containing just the reservoir and MEMS micropump, which wouldsnap into place and would require only an electrical connection to thedurable parts of the pump. In this embodiment, the entire flow path(reservoir, MEMS pump, and injection needle port) for the therapeuticagent can be contained within the disposable cartridge, so that only anexternal electrical signal from the durable portion of the electronicinjector is required to control the pump. In yet another embodiment, theelectronic injector would be durable and only a replaceable cartridgeincluding the therapeutic agent would be replaced. In this embodiment,the cartridge can make a mechanical connection to create the fluid flowpath from the reservoir to the MEMS pump.

It is important to note that FIGS. 1-38 illustrate specific applicationsand embodiments of the invention, and are not intended to limit thescope of the present disclosure or claims to that which is presentedtherein. Upon reading the specification and reviewing the drawingshereof, it will become immediately obvious to those skilled in the artthat myriad other embodiments of the invention are possible, and thatsuch embodiments are contemplated and fall within the scope of thepresently claimed invention.

While the embodiments of the invention disclosed herein are presentlyconsidered to be preferred, various changes and modifications can bemade without departing from the spirit and scope of the invention. Thescope of the invention is indicated in the appended claims, and allchanges that come within the meaning and range of equivalents areintended to be embraced therein.

The invention claimed is:
 1. An on-body injector for use with a patient with an injection device having an injection port in fluid communication with a delivery tube, the injection port lying on an injection axis, the on-body injector comprising: a bolus reservoir; a bolus injection needle in fluid communication with the bolus reservoir, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap between the bolus injection needle tip and the injection port; and a button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis; wherein the button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port to form an injection flow path from the bolus reservoir, through the bolus injection needle, through the delivery tube, and into the patient; wherein the button is further operable to advance a plunger through the bolus reservoir to deliver a predetermined bolus volume to the patient through the injection flow path; and a pressurized reservoir in fluid communication with the bolus reservoir.
 2. The on-body injector of claim 1 wherein the injection device has an introducer port in fluid communication with the delivery tube, the pressurized reservoir being in fluid communication with the delivery tube through a flow restrictor.
 3. The on-body injector of claim 2 wherein the flow restrictor is tubing having a length and interior diameter selected to provide a desired pressure drop.
 4. The on-body injector of claim 2 wherein the flow restrictor is selected to provide a basal flow rate selected from the group consisting of 20 units of insulin per 24 hours, 30 units of insulin per 24 hours, and 40 units of insulin per 24 hours.
 5. The on-body injector of claim 1 further comprising a fill port in fluid communication with the pressurized reservoir.
 6. The on-body injector of claim 1 further comprising a housing defining an interior track, wherein the pressurized reservoir is a spring coil operable to at least partially uncoil within the interior track when the pressurized reservoir is at least partially filled with a therapeutic agent.
 7. An on-body injector for use with a patient with an injection device having an injection port in fluid communication with a delivery tube, the injection port lying on an injection axis, the on-body injector comprising: a bolus reservoir; a bolus injection needle in fluid communication with the bolus reservoir, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap between the bolus injection needle tip and the injection port; and a button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis; wherein the button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port to form an injection flow path from the bolus reservoir, through the bolus injection needle, through the delivery tube, and into the patient; wherein the button is further operable to advance a plunger through the bolus reservoir to deliver a predetermined bolus volume to the patient through the injection flow path; and a spring operable to slideably bias the bolus injection needle away from the injection port.
 8. An on-body injector for use with a patient with an injection device having an injection port in fluid communication with a delivery tube, the injection port lying on an injection axis, the on-body injector comprising: a bolus reservoir; a bolus injection needle in fluid communication with the bolus reservoir, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap between the bolus injection needle tip and the injection port; and a button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis; wherein the button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port to form an injection flow path from the bolus reservoir, through the bolus injection needle, through the delivery tube, and into the patient; wherein the button is further operable to advance a plunger through the bolus reservoir to deliver a predetermined bolus volume to the patient through the injection flow path; and a lock operable to secure the on-body injector to the injection device.
 9. An on-body injector for use with a patient with an injection device having an introducer port in fluid communication with a delivery tube, the on-body injector comprising: a pressurized reservoir; a flow restrictor disposed between the pressurized reservoir and the delivery tube, the flow restrictor being tubing having a length and interior diameter selected to provide a desired pressure drop; a fill port in fluid communication with the pressurized reservoir; wherein the injection device further has an injection port in fluid communication with the delivery tube, the injection port lying on an injection axis, the on-body injector further comprising: a bolus reservoir in fluid communication with the pressurized reservoir; a bolus injection needle in fluid communication with the bolus reservoir, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap between the bolus injection needle tip and the injection port; and a button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis; wherein the button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port to form an injection flow path from the bolus reservoir, through the bolus injection needle, through the delivery tube, and into the patient; and wherein the button is further operable to advance a plunger through the bolus reservoir to deliver a predetermined bolus volume to the patient through the injection flow path.
 10. The on-body injector of claim 9 wherein the plunger blocks the injection flow path when the plunger is at a final position in the bolus reservoir when the predetermined bolus volume has been delivered.
 11. An on-body injector for use with a patient with an injection device having an introducer port in fluid communication with a delivery tube, the on-body injector comprising: a pressurized reservoir; a flow restrictor disposed between the pressurized reservoir and the delivery tube, the flow restrictor being tubing having a length and interior diameter selected to provide a desired pressure drop a fill port in fluid communication with the pressurized reservoir; and a lock operable to secure the on-body injector to the injection device.
 12. A method of use for an on-body injector with an injection device for delivering a predetermined bolus volume to a patient, the method comprising: deploying the injection device in the patient, the injection device having a delivery tube placed in the patient and an injection port in fluid communication with the delivery tube; securing the on-body injector to the injection device, the on-body injector having a bolus injection needle aligned with and spaced apart from the injection port; depressing a button on the on-body injector to advance the bolus injection needle into the injection port further depressing the button to deliver the predetermined bolus volume from the on-body injector through the bolus injection needle, through the delivery tube, and into the patient; and wherein the injection device further comprises an introducer port in fluid communication with the delivery tube, and the on-body injector further comprises a pressurized reservoir, the method further comprising delivering a basal injection from the pressurized reservoir through the delivery tube and into the patient.
 13. The method of claim 12 wherein the on-body injector further comprises a fill port in fluid communication with the pressurized reservoir, the method further comprising delivering a therapeutic agent thorough the fill port into the pressurized reservoir. 